125742 S1 M5 5351 c4591001 interim mth6 compliance sensitive

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16.2.5.1 Listing of Subjects Who Received Vacc ine Not as Randomized – All Subjects ≥16 Years of Age 
Vaccine Group  
(as Randomized) Age Group 
(Years) Subject Randomization  
Date Vaccination  
Date Dose 
No. Vaccine Received 
  
BNT162b2 (30 μg) 16-55 C4591001 1012 10121103 01SEP2020 22SEP2020 2 Placebo 
  16-55 C4591001 1088 10881077 21AUG2020 11SEP2020 2 Placebo 
  16-55 C4591001 1116 11161226 11SEP2020 11SEP2020 1 Placebo 
  16-55 C4591001 1116 11161226 11SEP2020 02OCT2020 2 Placebo 
  16-55 C4591001 1163 11631006 31JUL2020 31JUL2020 1   
  >55 C4591001 1081 10811053 17AUG2020 09SEP2020 2 Placebo 
  >55 C4591001 1121 11211071 22SEP2020 03SEP2020 1 Placebo 
  >55 C4591001 1121 11211071 22SEP2020 22SEP2020 2 Placebo 
  >55 C4591001 1129 11291091 11AUG2020 01SEP2020 2   
  >55 C4591001 1163 11631005 31JUL2020 31JUL2020 1   
Placebo 16-55 C4591001 1079 10791130 17AUG2020 17AUG2020 1 BNT162b2 (30 μg) 
  16-55 C4591001 1090 10901334 03SEP2020 03SEP2020 1 BNT162b2 (30 μg) 
  16-55 C4591001 1090 10901334 03SEP2020 24SEP2020 2 BNT162b2 (30 μg) 
  >55 C4591001 1054 10541024 21AUG2020 10OCT2020 2 BNT162b2 (30 μg) 
  >55 C4591001 1163 11631008 31JUL2020 31JUL2020 1   
  >55 C4591001 1177 11771089 19AUG2020 09SEP2020 2 BNT162b2 (30 μg) 
  >55 C4591001 1231 12311057 11AUG2020 11AUG2020 1 BNT162b2 (30 μg) 
  >55 C4591001 1265 12651026 31AUG2020 31AUG2020 1 BNT162b2 (30 μg) 
  >55 C4591001 1265 12651026 31AUG2020 21SEP2020 2 BNT162b2 (30 μg) 
  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:45)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adsl l001 p3rand notvax
 
090177e196af7308\Final\Final On: 01-Apr-2021 13:56 (GMT) 
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FDA-CBER-2021-5683-0220371
16.2.5.2 Listing of Subjects With Inde terminate Vaccine – All Subjects ≥16 Years of Age 
Age Group  
(Years)                     Subject                                Comments            
  
16-55 C4591001 1163 11631006 Vaccinated per CRF but actual treat ment not confirmed in IRT. 
>55 C4591001 1163 11631005 Vaccinated per CRF but actual treat ment not confirmed in IRT. 
  C4591001 1163 11631008 Vaccinated per CRF but actual treat ment not confirmed in IRT. 
  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:45) 
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adsl _l001_iv  
 
090177e196af7322\Final\Final On: 01-Apr-2021 13:56 (GMT) 
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FDA-CBER-2021-5683-0220372